FDAFDA recall Z-0137-2027 · Oct 21, 2026
Medtronic Sofamor Danek USA Inc: Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with a recall
Recall found
Product
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch" and Orthoblend are produced from a fiber form of DBM Crunch" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.
Reason for recall
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051, specifically: A62881-034, A62881-035, A62881-036, A62881-037, A62881-038, A62881-039, A62881-040, A62881-041, A62881-042, A62881-043, A62881-044, A62881-045, A62881-046, A62881-047, A62881-048, A62881-049, A62881-050, A62881-051
- Quantity
- 18
- Distribution
- US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
- Recalling firm
- Medtronic Sofamor Danek USA Inc, Memphis, TN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-12
Source: openFDA enforcement record Z-0137-2027 · search recall number Z-0137-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.